Survivorship Clinic for long-term survivors with gynecological cancer

Not Applicable

• Conditions: C56; C57; C48; Malignant neoplasm of ovary; Malignant neoplasm of other and unspecified female genital organs; Malignant neoplasm of retroperitoneum and peritoneum; C55; C53; C54; C57.8

• Registration Number: DRKS00028471
• Lead Sponsor: Klinik für Gynäkologie mit Zentrum für onkologische Chirurgie; Charité – Universitätsmedizin Berlin; Campus Virchow-Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Study Completion: 2024-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 373

Inclusion Criteria

Initial diagnosis of a gynecologic tumor disease (ovarian, endometrial, or cervical cancer) at least five years ago.

Exclusion Criteria

- Insufficient written and spoken German language skills
- Individuals who are not capable of giving consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in health-related quality of life after 12 months compared to baseline. A clinically relevant improvement is defined as an increase in quality of life by at least 6 points in at least one of the two summated scores of the SF-36 (physical or psychological summated score).

Secondary Outcome Measures

Name	Time	Method
Main clinical secondary endpoints: Cancer-specific quality of life (QLQ-C30), tumor entity-specific quality of life (ovary-28, cervix-24, endometrium-24), health-related quality of life (physical and mental sum score of the SF-36), frequency and severity of long-term side effects (including fatigue, sleep disturbances, depression, polyneuropathy, chemobrain), physical activity, bone density and cardiotoxicity, hand strength, nutritional status and antioxidant status, mortality. All secondary endpoints are assessed at 12 months and in some cases additionally at 3, 6, and 9 months.<br><br>Main health economic secondary endpoints (secondary data): health care resource utilization before and during intervention (e.g., outpatient physician contacts, inpatient treatments), direct health care costs, indirect costs due to sick days, type and frequency of physician-coded long-term adverse events.<br>